HiRes 90K™ Replacement Magnet

GUDID 00840094456198

1

Advanced Bionics, LLC

Cochlear implant implantable magnet
Primary Device ID00840094456198
NIH Device Record Keya0ba66b6-d6d4-4559-a0d3-9bb9e6459781
Commercial Distribution StatusIn Commercial Distribution
Brand NameHiRes 90K™ Replacement Magnet
Version Model NumberCI-1412
Company DUNS803906382
Company NameAdvanced Bionics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840094456198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-31
Device Publish Date2025-07-23

Devices Manufactured by Advanced Bionics, LLC

00840094456198 - HiRes 90K™ Replacement Magnet2025-07-311
00840094456198 - HiRes 90K™ Replacement Magnet2025-07-31 1
00840094481640 - HiRes™ Ultra CI HiFocus™ SlimJ Electrode2024-08-26
00840094483156 - HiRes™ Ultra CI HiFocus™ MS Electrode2024-08-26
00840094455962 - HiRes™ Ultra CI HiFocus™ MS Electrode2024-08-19
00840094455993 - HiRes™ Ultra 3D CI HiFocus™ MS Electrode2024-08-19
00840094456020 - HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode2024-08-19
00840094448247 - Auria™ PowerCel™ Slim2024-07-23 Silver Metallic
00840094448254 - Auria™ PowerCel™ Slim2024-07-23 Beige

Trademark Results [HiRes 90K]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HIRES 90K
HIRES 90K
78174451 2872973 Live/Registered
ADVANCED BIONICS AG
2002-10-15

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.